Drug updated on 9/4/2024
Dosage Form | Injection (intravenous: 35 mcg) |
Drug Class | CD19-directed CD3 T-cell engagers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
- Indicated for the treatment of adults and pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
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Summary
- Blincyto (blinatumomab) is indicated for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, and for the treatment of adults and pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).
- This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
- Blinatumomab exhibited a complete remission (CR) rate of 31% to 56% across different studies, with higher rates in patients with bone marrow (BM) blasts <50%. Specifically, CR rates were 56% in pediatric patients with relapsed/refractory B-ALL, 54% in adult and pediatric patients with B-ALL, 45% in relapsed/refractory ALL, and 20% in NHL patients.
- Median overall survival with blinatumomab was 7.7 months versus 4.0 months with standard chemotherapy. Pediatric patients with relapsed/refractory B-ALL had an overall survival (OS) of 0.43. The 2-year OS was 25% for blinatumomab compared to 55% for CAR T-cell therapy.
- Minimal Residual Disease response rates varied between 31% and 51%, with a rate of 51% in pediatric patients with relapsed/refractory B-ALL and a pooled rate of 42% in ALL patients.
- The event-free survival rate in pediatric patients was 30%, while the median relapse-free survival (RFS) was 6.02 months. The 2-year RFS was 22% with blinatumomab compared to 40% with CAR T-cell therapy.
- The pooled occurrence rate of grade ≥3 adverse effects (AEs) was 80%, with specific incidences for neurological toxicity at 7% and cytokine release syndrome (CRS) at 3%.
- The incidence of grade ≥3 neurological toxicity was 7%, and the risk of encephalopathy was significantly higher with blinatumomab compared to chemotherapy (relative risk, 8.90).
- Blinatumomab was associated with a lower rate of grade ≥3 hematological toxicity, CRS, and neurological events compared to CAR T-cell therapy, and had fewer grade ≥3 AEs compared to chemotherapy, including a lower risk of febrile neutropenia and infections.
- Specific populations mentioned include pediatric patients with relapsed/refractory B-ALL, adults with relapsed/refractory B-ALL, and children with B-precursor ALL and B-cell lymphoma. Subgroup findings highlighted that CR rates were higher in patients with bone marrow blasts <50%, and prior allogeneic hematopoietic stem cell transplant did not affect CR rates. Blinatumomab may be particularly beneficial as a bridge to hematopoietic stem cell transplantation, with careful monitoring of safety profiles, especially in pediatric populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Blincyto (blinatumomab) Prescribing Information. | 2024 | Amgen Inc., Thousand Oaks, California |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ESMO clinical practice guideline interim update on the use of targeted therapy in acute lymphoblastic leukaemia. | 2023 | Annals of Oncology |
Acute lymphoblastic leukemia in adults. | 2022 | Alberta Health Services |
Acute lymphoblastic leukemia, version 2.2021, NCCN clinical practice guidelines in oncology. | 2021 | Journal of the National Comprehensive Cancer Network |
The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of acute leukemia. | 2020 | Journal for ImmunoTherapy of Cancer |